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利用者名:
UMIN ID:

試験進捗状況 試験終了/Completed
UMIN試験ID UMIN000019701
受付番号 R000022756
科学的試験名 急性肺損傷(ALI)/急性呼吸促迫症候群(ARDS)に関する多施設共同前向き観察研究
一般公開日(本登録希望日) 2015/11/16
最終更新日 2020/11/12

※ 本ページ収載の情報は、臨床試験に関する情報公開を目的として、UMINが開設しているUMIN臨床試験登録システムに提供された臨床試験情報です。
※ 特定の医薬品や治療法等については、医療関係者や一般の方に向けて広告することは目的としていません。


基本情報/Basic information
一般向け試験名/Public title 急性肺損傷(ALI)/急性呼吸促迫症候群(ARDS)に関する多施設共同前向き観察研究 A multicenter, prospective observational study for the epidemiology of acute lung injury and acute respiratory distress syndrome
一般向け試験名略称/Acronym ALI/ARDSの疫学 (FORECAST ARDS) Epidemiology of ALI/ARDS (FORECAST ARDS)
科学的試験名/Scientific Title 急性肺損傷(ALI)/急性呼吸促迫症候群(ARDS)に関する多施設共同前向き観察研究 A multicenter, prospective observational study for the epidemiology of acute lung injury and acute respiratory distress syndrome
科学的試験名略称/Scientific Title:Acronym ALI/ARDSの疫学 (FORECAST ARDS) Epidemiology of ALI/ARDS (FORECAST ARDS)
試験実施地域/Region
日本/Japan

対象疾患/Condition
対象疾患名/Condition 急性肺損傷(ALI)、急性呼吸促迫症候群(ARDS) Acute lung injury, Acute respiratory distress syndrome
疾患区分1/Classification by specialty
救急医学/Emergency medicine
疾患区分2/Classification by malignancy 悪性腫瘍以外/Others
ゲノム情報の取扱い/Genomic information いいえ/NO

目的/Objectives
目的1/Narrative objectives1 米国欧州合意会議(AECC)定義、およびBerlin定義により診断されるALI/ARDSの疫学、病態生理と発生機序、診断・治療法を明らかにする。 The aim of this study was to elucidate the epidemiology, pathophysiology/pathogenesis, and diagnosis/treatment of acute lung injury (ALI) / acute respiratory distress syndrome (ARDS) diagnosed by the AECC and Berlin definitions.
目的2/Basic objectives2 その他/Others
目的2 -その他詳細/Basic objectives -Others 28日および病院死亡率 28-day and hospital mortality
試験の性質1/Trial characteristics_1 探索的/Exploratory
試験の性質2/Trial characteristics_2
試験のフェーズ/Developmental phase

評価/Assessment
主要アウトカム評価項目/Primary outcomes ALI/ARDSの疫学(病院死亡率) The epidemiology of ALI/ARDS (hospital mortality)
副次アウトカム評価項目/Key secondary outcomes 1.ALIARDSの病態生理と発症機序
2.ALI/ARDSの診断および治療
1. The pathophysiology and pathogenesis of ALI/ARDS
2. The diagnosis and therapeutic methods of ARDS

基本事項/Base
試験の種類/Study type 観察/Observational

試験デザイン/Study design
基本デザイン/Basic design
ランダム化/Randomization
ランダム化の単位/Randomization unit
ブラインド化/Blinding
コントロール/Control
層別化/Stratification
動的割付/Dynamic allocation
試験実施施設の考慮/Institution consideration
ブロック化/Blocking
割付コードを知る方法/Concealment

介入/Intervention
群数/No. of arms
介入の目的/Purpose of intervention
介入の種類/Type of intervention
介入1/Interventions/Control_1

介入2/Interventions/Control_2

介入3/Interventions/Control_3

介入4/Interventions/Control_4

介入5/Interventions/Control_5

介入6/Interventions/Control_6

介入7/Interventions/Control_7

介入8/Interventions/Control_8

介入9/Interventions/Control_9

介入10/Interventions/Control_10


適格性/Eligibility
年齢(下限)/Age-lower limit
16 歳/years-old 以上/<=
年齢(上限)/Age-upper limit

適用なし/Not applicable
性別/Gender 男女両方/Male and Female
選択基準/Key inclusion criteria AECC (American European Consensus Conference)定義を満たすALI/ARDS患者 Patients who met the definition of ALI/ARDS according to the AECC (American European Consensus Conference)
除外基準/Key exclusion criteria なし None
目標参加者数/Target sample size 500

責任研究者/Research contact person
責任研究者/Name of lead principal investigator
ミドルネーム
丸藤
Satoshi
ミドルネーム
GANDO
所属組織/Organization 北海道大学大学院医学研究科 Hokkaido University Graduate School of Medicine
所属部署/Division name 救急医学分野 Acute and Critical Care Medicine
郵便番号/Zip code 060-8638
住所/Address 札幌市北区北15条西7丁目 N15W7, Kita-ku, Sapporo
電話/TEL +81-11-706-7377
Email/Email gando@med.hokudai.ac.jp

試験問い合わせ窓口/Public contact
試験問い合わせ窓口担当者/Name of contact person
修太
ミドルネーム
福田
Shuta
ミドルネーム
Fukuda
組織名/Organization 日本救急医学会 Japanese Association for Acute Medicine
部署名/Division name 事務局 Office
郵便番号/Zip code 113-0033
住所/Address 東京都文京区本郷3-3-12 3-3-12, Hongo, Bunkyo-ku, Tokyo
電話/TEL +81-3-5840-9870
試験のホームページURL/Homepage URL http://www.jaam.jp/html/jaamforecast/index.html
Email/Email jaam-10@umin.ac.jp

実施責任組織/Sponsor
機関名/Institute その他 Japanese Association for Acute Medicine
機関名/Institute
(機関選択不可の場合)
日本救急医学会
部署名/Department

研究費提供組織/Funding Source
機関名/Organization その他 Japanese Association for Acute Medicine, Japan Society for the Promotion of the Science
機関名/Organization
(機関選択不可の場合)
日本救急医学会、日本学術振興会
組織名/Division
組織の区分/Category of Funding Organization その他/Other
研究費拠出国/Nationality of Funding Organization 日本 Japan

その他の関連組織/Other related organizations
共同実施組織/Co-sponsor

その他の研究費提供組織/Name of secondary funder(s)


IRB等連絡先(公開)/IRB Contact (For public release)
組織名/Organization 北海道大学病院自主臨床試験審査委員会 Hokkaido University Hospital Clinical Research and Medical Innovation Center
住所/Address 札幌市北区北14条西5丁目 N14W5, Kita-ku, Sapporo
電話/Tel +81-11-701-7636
Email/Email crjimu@huhp.hokudai.ac.jp

他機関から発行された試験ID/Secondary IDs
他機関から発行された試験ID/Secondary IDs いいえ/NO
試験ID1/Study ID_1
ID発行機関1/Org. issuing International ID_1

試験ID2/Study ID_2
ID発行機関2/Org. issuing International ID_2

治験届/IND to MHLW

試験実施施設/Institutions
試験実施施設名称/Institutions

その他の管理情報/Other administrative information
一般公開日(本登録希望日)/Date of disclosure of the study information
2015 11 16

関連情報/Related information
プロトコル掲載URL/URL releasing protocol http://www.jaam.jp/html/jaamforecast/index.html
試験結果の公開状況/Publication of results 最終結果が公表されている/Published

結果/Result
結果掲載URL/URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/31348148
組み入れ参加者数/Number of participants that the trial has enrolled 166
主な結果/Results CONCLUSIONS: Our study included a greater percentage of patients with ARDS with high severity and found that the overall mortality was 38%. The management of ARDS in Japan was characterized by high the utilization rate of glucocorticoids, which was positively associated with mortality. CONCLUSIONS: Our study included a greater percentage of patients with ARDS with high severity and found that the overall mortality was 38%. The management of ARDS in Japan was characterized by high the utilization rate of glucocorticoids, which was positively associated with mortality.
主な結果入力日/Results date posted
2020 05 13
結果掲載遅延/Results Delayed
結果遅延理由/Results Delay Reason

最初の試験結果の出版日/Date of the first journal publication of results
2020 05 01
参加者背景/Baseline Characteristics PURPOSE: Acute respiratory distress syndrome (ARDS) remains a major cause of death. Epidemiology should be continually examined to refine therapeutic strategies for ARDS. We aimed to elucidate demographics, treatments, and outcomes of ARDS in Japan. PURPOSE: Acute respiratory distress syndrome (ARDS) remains a major cause of death. Epidemiology should be continually examined to refine therapeutic strategies for ARDS. We aimed to elucidate demographics, treatments, and outcomes of ARDS in Japan.
参加者の流れ/Participant flow METHODS: This is a prospective cohort study for ARDS. We included adult patients admitted to intensive care units through emergency and critical care departments who satisfied the American-European Consensus Conference (AECC) acute lung injury (ALI) criteria. In addition, the fulfillment of the Berlin definition was assessed. Logistic regression analyses were used to examine the association of independent variables with outcomes. METHODS: This is a prospective cohort study for ARDS. We included adult patients admitted to intensive care units through emergency and critical care departments who satisfied the American-European Consensus Conference (AECC) acute lung injury (ALI) criteria. In addition, the fulfillment of the Berlin definition was assessed. Logistic regression analyses were used to examine the association of independent variables with outcomes.
有害事象/Adverse events Not applicable Not applicable
評価項目/Outcome measures RESULTS: Our study included 166 patients with AECC ALI from 34 hospitals in Japan; among them, 157 (94.6%) fulfilled the Berlin definition. The proportion of patients with PaO2/FIO2 lower than 100, patients under invasive positive pressure ventilation (IPPV), and in-hospital mortality was 39.2%, 92.2%, and 38.0% for patients with AECC ALI and 38.9%, 96.8%, and 37.6% for patients with Berlin ARDS, respectively. The area of lung infiltration was independently associated with outcomes of ARDS. Low-mid-tidal volume ventilation was performed in 75% of patients under IPPV. Glucocorticoid use was observed in 54% patients, and it was positively associated with mortality. RESULTS: Our study included 166 patients with AECC ALI from 34 hospitals in Japan; among them, 157 (94.6%) fulfilled the Berlin definition. The proportion of patients with PaO2/FIO2 lower than 100, patients under invasive positive pressure ventilation (IPPV), and in-hospital mortality was 39.2%, 92.2%, and 38.0% for patients with AECC ALI and 38.9%, 96.8%, and 37.6% for patients with Berlin ARDS, respectively. The area of lung infiltration was independently associated with outcomes of ARDS. Low-mid-tidal volume ventilation was performed in 75% of patients under IPPV. Glucocorticoid use was observed in 54% patients, and it was positively associated with mortality.
個別症例データ共有計画/Plan to share IPD

個別症例データ共有計画の詳細/IPD sharing Plan description


試験進捗状況/Progress
試験進捗状況/Recruitment status 試験終了/Completed
プロトコル確定日/Date of protocol fixation
2015 06 05
倫理委員会による承認日/Date of IRB
2016 10 28
登録・組入れ開始(予定)日/Anticipated trial start date
2016 04 01
フォロー終了(予定)日/Last follow-up date
2017 05 31
入力終了(予定)日/Date of closure to data entry
2017 07 31
データ固定(予定)日/Date trial data considered complete
2017 12 31
解析終了(予定)日/Date analysis concluded
2018 03 31

その他/Other
その他関連情報/Other related information 研究デザイン:コホート研究

対象者の募集方法:2016年1月-12月に研究参加施設の救急部門を受診または入院し、AECC ALI診断基準を満たし、除外基準の何れにも該当しない全員

測定項目:患者背景(年齢、性別、共存症)、原因疾患、重症度(P/F比)、検査所見、臓器不全、等と転帰(病院死亡率、28日死亡率、在院日数、人工呼吸器離脱率、等)との関連
Study design: Prospective cohort study

Patients enrollment method; We recruit all patients who visit ER or are admitted to a ward of the participated hospitals between January 1 and December 31, 2016, fulfilling the AECC ALI criteria, butnot any of exclusion criteria.

Data collection: Relationships between patients' background factors (age, gender, comorbidities, etc), predisposing diseases, disease severity (P/F ratio), laboratory findings, organ dysfunction, etc and outcome (hospital mortality, 28-day mortality, hospital stay, ventilator-free days, etc)

管理情報/Management information
登録日時/Registered date
2015 11 09
最終更新日/Last modified on
2020 11 12


閲覧ページへのリンク/Link to view the page
URL(日本語) https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000022756
URL(英語) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022756

研究計画書
登録日時 ファイル名

研究症例データ仕様書
登録日時 ファイル名

研究症例データ
登録日時 ファイル名


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